MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE HOLDINGS, INC. OPTIFLUX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number F160NR

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2022

Event Type  malfunction  

Event Description

Tablo set up appropriately with help of device representative."blood leak sensor" alarm triggered immediately after starting treatment, due to possible malfunction of optiflux dialyzer.Rep was called and he walked us through how to end treatment and to note lot# of dialyzer.He states this is not an uncommon issue as of late.We were unable to return the blood to pt (patient), so md notified of this and pt type and crossed for 2units prbcs (packed red blood cells).Will clean tablo device per protocol, obtain new cassette, new dialyzer and attempt to start ordered treatment again.

• Brand Name: OPTIFLUX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE HOLDINGS, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 15502837
• MDR Text Key: 300773703
• Report Number: 15502837
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022,02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: F160NR
• Device Catalogue Number: 0500316E
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Sex: Male